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临床试验/NCT03635840
NCT03635840已完成不适用

The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock

Indonesia University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
30-day-Mortality

研究概览

简要总结

Prevalence of cardiogenic shock in acute coronary syndrome patients is reported at about 5-8% with high fatality. Revascularization approach has already known as the standard of care, but the usage of intra-aortic balloon pump (IABP) as mechanical circulatory support is still a controversy. IABP SHOCK II trial revealed that short-term mortality did not improved by IABP but there are several essential variabels related to mortality that are not considered in the study which are IABP initiation time and weaning protocol.This study aim to evalute the effect of IABP prior to revascularization on mortality of patients with myocardial infarction complicated with shock.

92 subjects will be enrolled in this randomized controlled trial into two groups, with and without IABP. IABP group will be receiving the intervention prior to revascularization. The primary outcomes to be sought are in-hospital and 30-day mortality after revascularization. IABP effects measured by various indicators such as Global Longitudinal Strain by echocardiography on the 1st and 3rd day, NTproBNP and ST2 level on the 1st, 3rd and 5th day, effective lactate clearance and ureum creatinine level on the 1st and 3rd day and will be compared between two groups. Continous variabel will be presented in mean ± deviation standard or median, and analized with Student's t test or Mann-Whitney U test as appropriate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years old
  • Myocardial infarction patients complicated with shock
  • Willing to enroll in the study (signed consent)

排除标准

  • Age greater than 80 years old
  • Heart and lung resuscitation for more than 30 minutes
  • Cardiogenic shock onset >12 hours (if known) or >18 hours (if not known/patient presented in emergency department already with shock)
  • Mechanical complication of myocardial infarction
  • Moderate and severe aorta regurgitation
  • Peripheral artery disease making IABP unfeasible
  • Patients not receiving revascularization by percutaneous coronary intervention
  • Patients who died before IABP insertion
  • Care termination requested by family

结局指标

主要结局

30-day-Mortality

时间窗: 30 days

Mortality of patients 30 day after hospitalization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dafsah A. Juzar, MD

Interventional Cardiologist, Principal Investigator

Indonesia University

研究点 (2)

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